BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3000610 · Received March 12, 2013

    Report

    Report Number
    1525712-2013-01890
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Report Date
    February 13, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER PROVIDED, AT5044, IS FOR THE LEG RESTS, NOT THE DEVICE.

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. IVC TERRITORY BUSINESS MANAGER STATES THE PIN ON THE HINGE SLIDES OUT, CAUSING THE CALF PAD TO FALL OFF. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104174 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other